Combined Nipple Stimulation and Foley Balloon for Cervical Ripening

Summary

Labor induction rates have increased substantially worldwide, and successful cervical ripening remains a key determinant of induction outcomes. Mechanical cervical ripening with a Foley balloon catheter is widely used and considered safe, while nipple stimulation promotes endogenous oxytocin release and represents a physiologic method for stimulating uterine contractions. However, the combined effect of nipple stimulation and balloon catheter use has not been systematically evaluated.

This prospective, randomized, double-blinded controlled trial will assess whether the addition of nipple stimulation to Foley balloon catheter cervical ripening improves Bishop score and shortens the induction-to-delivery interval compared with balloon catheter alone. Term pregnant patients (37-42 weeks' gestation) with a singleton, cephalic pregnancy and an unfavorable cervix (Bishop score \<6) requiring labor induction will be randomized to receive either Foley balloon catheter plus standardized nipple stimulation or Foley balloon catheter alone.

The primary outcomes are change in Bishop score after catheter removal and time from catheter insertion to delivery. Secondary outcomes include need for additional induction methods, mode of delivery, maternal and neonatal outcomes, pain, patient satisfaction, and breastfeeding rates. The study aims to evaluate the efficacy and safety of incorporating a physiologic intervention into standard mechanical cervical ripening.

Conditions

• Induction of Labor
• Cervical Ripening

Interventions

PROCEDURE

Foley balloon catheter with nipple stimulation

Mechanical cervical ripening will be performed using a single-balloon Foley catheter inserted transcervically under sterile conditions. The catheter balloon will be positioned above the internal cervical os and inflated with 60 mL of sterile saline solution. The catheter will remain in place for up to 12 hours or until spontaneous expulsion, onset of active labor, rupture of membranes, uterine tachysystole, or non-reassuring fetal heart rate tracing, whichever occurs first. In participants randomized to the intervention arm, cervical ripening with the Foley catheter will be combined with nipple stimulation using an electric breast pump according to a standardized protocol, beginning one hour after catheter insertion. Participants in the control arm will undergo cervical ripening with the Foley catheter alone, without nipple stimulation. Cervical status will be assessed before catheter insertion and after catheter removal using the Bishop score. Subsequent labor management will follow

PROCEDURE

Mechanical cervical ripening with Foley catheter

Mechanical cervical ripening will be performed using a single-balloon Foley catheter inserted transcervically under sterile conditions. The catheter balloon will be positioned above the internal cervical os and inflated with 60 mL of sterile saline solution. The catheter will remain in place for up to 12 hours or until spontaneous expulsion, onset of active labor, rupture of membranes, uterine tachysystole, or non-reassuring fetal heart rate tracing, whichever occurs first.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya

  lead OTHER_GOV

Principal Investigators

• Maya Frank Wolf, Prof. · Galilee Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-01-01

Completion

2028-01-01